FDA's Rejection Of Generic OxyContin May Have Side Effects

OxyContin's long-acting formulation makes it popular but also prone to abuse.

Toby TalbotAP

Originally published on April 19, 2013 2:08 pm

Banning cheaper, generic forms of a dangerous drug sounds like a worthy idea.

But the Food and Drug Administration's decision to bar generic OxyContin may also push patients towards less effective drugs without eliminating the risk of addiction, experts say.

"Obviously, there's a cost issue," says Lynn Webster, president of the American Academy of Pain Medicine. "Not having generics means this type of medication is going to be more expensive."

On Tuesday, the FDA said that it won't approve generic versions of the original formulation of OxyContin, a long-acting narcotic pain medication, which went off patent that day.

Normally, the end of the patent's life would open the door to generics. But drugmakers must now develop their own abuse-resistant versions if they want to compete for a share of the lucrative market.

In 2010, Purdue Pharma LP replaced the original OxyContin with an abuse-resistant form, in an effort to reduce deaths and overdoses caused by the powerful pain medication, which was licensed in 1995.

From 1999 to 2006, deaths involving prescription opioid painkillers more than tripled, according to the federal Centers for Disease Control and Prevention. In 1997, Purdue pleaded guilty to federal charges that it misbranded the drug by claiming that it was safer and less addictive than short-acting narcotic drugs like Vicodin and Percocet.

The new version of OxyContin includes an ingredient, a polymer, that makes it harder to crush and snort or inject to get a quick, heroin-like high.

When the new version was introduced, Purdue pulled the original OxyContin off the market. The patent on the new version runs until 2025.

That's good news for Purdue. Even though OxyContin sales dropped after the abuse-deterrent version was introduced, the medicine still accounts for one-third of the market for prescription painkillers, with $2.8 billion in sales, according to IMS Health.

The average cost for a pill is $7.50, or $450 per bottle of 100, according to Purdue.

"The issue is really about the generic and the availability issue," says Dr. Joe Ross, an assistant professor at the Yale School of Medicine who studies drug and device safety. "Why do they essentially get a patent extension when they had an unsafe drug on the market for many years? Why would the FDA reward them?"

The high cost of OxyContin does drive prescribing decisions, Webster says, and doctors may switch to methadone and other less-convenient options when a patient's insurance won't cover OxyContin, which provides extended pain relief.

It would be "disastrous" to market generic OxyContin without making it abuse-resistant, Webster says. "There should be no opioids on the market that don't have some abuse-deterrent formulation."

Some abusers of opioids have shifted away from OxyContin and Opana, a long-acting prescription opioid made by Endo Pharmaceuticals, since the abuse-deterrent forms were released. But about one-quarter of abusers say they've figured out how to defeat the deterrent, according to a 2012 article in the New England Journal of Medicine.

Just because a pill is abuse-deterrent doesn't mean it's harmless.

"A pill that's harder to snort or inject isn't necessarily less addictive," says Andrew Kolodny, head of psychiatry at Maimonides Medical Center in New York, who studies policy on opioid drugs. People also get addicted by swallowing pills, he notes.

"One of my concerns is that this new rule could set up an arms race for the pharmaceutical companies to create abuse-deterrent versions because they have patent protection," Kolodny told Shots. "You'll see marketing to prescribers that these pills are less addictive. That could potentially make things worse."